Oct 16, 2017

Plain Language Summary Guidance Document Submitted to the FDA – open for comments

The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants. The document was endorsed by 36 signatories, including patient advocacy groups and professional associations. This document is currently available for public comment on the FDA website, and we encourage you to comment.